The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for Novo Nordisk’s Wegovy (semaglutide), allowing its use to reduce the risk of serious cardiovascular events in overweight or obese adults.
The approval covers heart attacks and strokes in such individuals with established cardiovascular disease.
Previously, semaglutide was approved in the UK for the treatment of obesity and weight management, to be used alongside diet, physical activity, and behavioural support. It is administered via a pre-filled pen.
Semaglutide, a GLP-1 receptor agonist, mimics the GLP-1 hormone that regulates blood sugar levels.
The drug binds to GLP-1 receptors on pancreatic cells, enhancing insulin secretion in response to meals, reducing glucagon release, and slowing gastric emptying. This mechanism aids in weight loss.
MHRA Innovative Medicines Deputy Director Shirley Hopper said: “Our key priority is enabling access to high quality, safe and effective medical products.
“We’re assured that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this medicine have been met. This treatment option that prevents heart disease and strokes is an important step forward in tackling the serious health consequences of obesity.”
The MHRA’s latest approval designates semaglutide as the first weight loss drug to be prescribed for the prevention of cardiovascular events, including cardiovascular death, non-fatal heart attack, and non-fatal stroke. This indication applies to individuals with established cardiovascular disease and a Body Mass Index (BMI) of 27 kg/m² or higher.
This decision is based on new data from a post-approval clinical study. The study showed that semaglutide (2.4mg once weekly by subcutaneous injection, for up to five years) reduces the incidence of major adverse cardiovascular events (MACE) compared to a placebo.
In a multi-national, placebo-controlled double-blind trial involving over 17,600 participants, Wegovy was found to lower the risk of MACE by 20%. Specifically, 6.5% of participants who received Wegovy experienced such events, compared to 8% in the placebo group.
